Label: AL0076001 ALBA BOTANICA ACNEDOTE DEEP PORE WASH- salicylic acid lotion

  • NDC Code(s): 61995-2060-6
  • Packager: The Hain Celestial Group, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 12, 2021

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    Salicylic Acid 2.0%

  • INDICATIONS & USAGE

    • For the treatment of acne
  • WARNINGS

    For external use only. Using other topical acne medications at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs,only one drug should be used unless directed by a doctor.

    Avoid direct contact with eyes. If contact occurs, flush thoroughly with water.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Apply to wet face and massage into a foamy lather. Rinse throughly. Use tvice a day.For best results follow with Alba Botanica Deep Clean Astrigen.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Center right away.

  • INACTIVE INGREDIENT

    Water, Coco-Betaine, Disodium Cocoyl Glutamate, Sodium Chloride, Cocamidopropyl Betaine, Glycerin, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Mentha Piperita (Peppermint) Oil, Azardirachta Indica Leaf Extract (1), Camellia Sinensis Leaf Extract (1), HamamelisVirginiana (Witch Hazel) Water, Melissa Officinalis Leaf Extract, Salix Alba (Willow) Bark Extract (1), Urtica Dioica (Nettle) Extract, Alcohol (1), Citric Acid, Dehydroacetic Acid, Benzoic Acid, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate.

    (1) Cerified Organic Ingredient

  • PURPOSE

    Acne Treatment

  • PRINCIPAL DISPLAY PANEL

    bottle label

  • INGREDIENTS AND APPEARANCE
    AL0076001 ALBA BOTANICA ACNEDOTE DEEP PORE WASH 
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCO-BETAINE (UNII: 03DH2IZ3FY)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    DISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-2060-6177 g in 1 BOTTLE; Type 0: Not a Combination Product11/29/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/29/2017
    Labeler - The Hain Celestial Group, Inc. (117115556)
    Registrant - The Hain Celestial Group, Inc (081512382)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.081512382manufacture(61995-2060)
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